[ad_1]
The vaccine is administered intramuscularly after dilution as a 2-dose schedule (0.3 ml each) at least 21 days apart.
Very common side effects seen during clinical trials are headache, localized joint pain, muscle aches, injection site pain and injection site swelling, fatigue, chills, and after the second dose of the vaccine. . I remember a higher frequency of fever was observed.
The full coronavirus leaflet has been published on the European Medicines Agency website and can be accessed HERE.
Therapeutic indications
Comirnaty is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus in people 16 years of age or older. The use of this vaccine must take into account the official recommendations.
Duration of protection
The duration of protection provided by the vaccine is unknown and is still being determined by ongoing clinical trials.
Limits of vaccine efficacy
As with any vaccine, vaccination with Comirnaty may not provide protection for all vaccinated people. People may not be fully protected within 7 days after the second dose of the vaccine.
Interactions with other drugs
No interaction studies have been performed. Co-administration of Comirnaty with other vaccines has not been studied.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the package leaflet.
Adverse reaction
The safety of Comirnaty was evaluated in participants with a minimum age of 16 years, in 2 clinical trials involving 21,744 participants who received at least one dose of Comirnaty.
In participants younger than 16 years, the most common adverse reactions were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30% ). , arthralgia (> 20%), fever and swelling at the injection site (> 10%), and these were generally mild or moderate in intensity and resolved within a few days of vaccination.
A slightly lower frequency of reactogenicity events was associated with advanced age.
Other recommendations
- Hypersensitivity and anaphylaxis.
Cases of anaphylaxis have been reported. In the event of an anaphylactic-type reaction after administration of the vaccine, appropriate medical treatment and supervision should always be available. Careful monitoring is recommended for at least 15 minutes after vaccination. People who have had anaphylaxis with the first dose of Comirnaty should not receive the second dose of the vaccine.
- Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions, can occur in association with vaccination as a psychogenic response to needle injection. It is important to take precautions to avoid injury from fainting.
Vaccination should be postponed in people with severe acute illness, fever, or acute infection. The presence of a mild infection and / or low fever is not a reason to postpone vaccination.
- Thrombocytopenia and bleeding disorders.
As with other intramuscular injections, the vaccine should be used with caution in people receiving anticoagulant therapy or those with thrombocytopenia or any bleeding disorder (eg, hemophilia), as bleeding or bruising may occur as a result of intramuscular administration. .
The efficacy, safety, and immunogenicity of the vaccine have not been evaluated in immunosuppressed individuals, including those receiving immunosuppressive therapy. The efficacy of Comirnaty may be decreased in immunosuppressed individuals.
